MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 35MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during an internal fixation surgery, a trigen low profile screw 5.0mm x 35mm was hard to insert completely, the surgeon applied strong force and caused the screw head broke off (it was fixed to the screw driver so it did not fell inside the patient).Threaded part of the screw remained inside the patient.Surgery was performed, without any delay, with the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was fractured directly below the head of the device.The other fractured portion was not returned as it was left inside of the patient.The clinical/medical evaluation concluded that one undated photo of the screw head was provided for review and confirms the reported.Without the requested clinical information, the reported screw breakage could not be further assessed.The trigen low profile screw is implantable, biocompatibility is not an issue.There is potential risk for corrosion and local irritation, migration, tissue inflammation, and/or pain.No further clinical/medical assessment is warranted at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.A potential probable cause could include but is not limited to excessive force or torque.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 35MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12471991
• Report Number: 1020279-2021-06848
• Device Sequence Number: 3391888
• Product Code: HSB
• UDI-Device Identifier: 00885556215692
• UDI-Public: 00885556215692
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71645035
• Device Catalogue Number: 71645035
• Device Lot Number: 20AM13200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention